NR 666.502(9)(b)2.
2. `Shipments rejected by the designated facility and shipped to an alternate facility.' For shipments rejected by the designated facility and shipped to an alternate facility, all of the following exception reporting requirements apply:
NR 666.502(9)(b)2.a.
a. If a healthcare facility does not receive a co
py of the manifest for a rejected shipment of the non-creditable hazardous waste pharmaceuticals that is forwarded
by the designated facility
to an alternate facility
using appropriate manifest procedures, with the signature of the owner or operator of the alternate facilit
y, within 60 calendar days of the date the non-creditable hazardous waste was accepted
by
the initial transporter forwarding the shipment of non-creditable hazardous waste pharmaceuticals from the designated facility
to the alternate facilit
y, the healthcare facility
shall submit all of the following to the department:
1) A legible copy of the original manifest, indicating that the healthcare facility has not received confirmation of delivery.
2) A handwritten or typed note on the original manifest itself, or on an attached sheet of paper, stating that the return copy was not received and explaining the efforts taken to locate the non-creditable hazardous waste pharmaceuticals and the results of those efforts.
NR 666.502(9)(c)
(c)
Additional reports. The department may require healthcare facilities to furnish additional reports concerning the quantities and disposition of non-creditable hazardous waste pharmaceuticals.
NR 666.502(10)
(10)
Recordkeeping by healthcare facilities for non-creditable hazardous waste pharmaceuticals. NR 666.502(10)(a)
(a) A healthcare facility shall keep a co
py
of each manifest signed in accordance with s.
NR 662.023 (1) for 3
years or until it receives a signed co
py
from the designated facility that received the non
-creditable hazardous waste pharmaceuticals. This signed copy
shall be retained as a record for at least 3
years from the date the waste was accepted
by the initial transporter
.
NR 666.502(10)(b)
(b) A healthcare facility shall keep a co
py
of each exception report for a period of at least 3
years from the date of the report.
NR 666.502(10)(c)
(c) A healthcare facility shall keep records of a
ny test results, waste ana
lyses, or other determinations made to support its hazardous waste determination consistent with s.
NR 662.011 (6), for at least 3
years from the date the waste was last sent to on
-site or off-site treatment, storage, or disposal. A healthcare facility
that manages all of its non-creditable non
-hazardous waste pharmaceuticals as non-creditable hazardous waste pharmaceuticals is not required to keep documentation of hazardous waste determinations.
NR 666.502(10)(d)
(d) The periods of retention referred to in this section are extended automatically
during the course of a
ny
unresolved enforcement action regarding the regulated activit
y, or as requested by
the department.
NR 666.502(10)(e)
(e) All records shall be readily available upon request by
the department
.
NR 666.502(11)
(11)
Response to spills of non-creditable hazardous waste pharmaceuticals at healthcare facilities. A healthcare facility
shall immediately contain all spills of non
-creditable hazardous waste pharmaceuticals and manage the spill clean-up materials as non
-creditable hazardous waste pharmaceuticals in accordance with the requirements of this subchapter.
NR 666.502(12)
(12)
Accepting non-creditable hazardous waste pharmaceuticals from an off-site healthcare facility that is a very small quantity generator. A healthcare facility
may accept non-creditable hazardous waste pharmaceuticals from an off-site healthcare facility
that is a very small quantity
generator under s.
NR 662.014, without a license or without having interim status, provided the receiving healthcare facilit
y meets all of the following:
NR 666.502(12)(a)
(a) Is under the control of the same person, as defined in s
. NR 660.10 (90), as the very
small quantity generator healthcare facility
that is sending the non-creditable hazardous waste pharmaceuticals off
-site, or has a contractual or other documented business relationship whereby the receiving healthcare facility supplies pharmaceuticals to the very small quantity generator healthcare facility. “Control,” for the purposes of this section, means the power to direct the policies of the healthcare facilit
y, whether
by the ownership of stock, voting rights, or otherwise, except that contractors who operate healthcare facilities on behalf of a different person as defined in s.
NR 660.10 may not be deemed to “control” such healthcare facilities.
NR 666.502(12)(b)
(b) Is operating under this subchapter for the management of its non-creditable hazardous waste pharmaceuticals.
NR 666.502(12)(c)
(c) Manages the non
-creditable hazardous waste pharmaceuticals that it receives from off-site in compliance with this subchapter.
NR 666.502(12)(d)
(d) Keeps records of the non-creditable hazardous waste pharmaceuticals shipments it receives from off-site for 3
years from the date that the shipment is received.
NR 666.502 History
History: CR 19-082: cr.
Register August 2020 No. 776, eff. 9-1-20; correction in (6) (b) (intro.) made under s.
35.17, Stats., and renumbering in (8) made under s.
13.92 (4) (b) 2., Stats.,
Register August 2020 No. 776.
NR 666.503
NR 666.503 Standards for healthcare facilities managing potentially creditable hazardous waste pharmaceuticals. NR 666.503(1)(1)
Hazardous waste determination for potentially creditable pharmaceuticals. A healthcare facility
that generates a solid waste that is a potentially
creditable pharmaceutical shall determine whether the potentially creditable pharmaceutical is a potentially
creditable hazardous waste pharmaceutical that is listed in subch.
D of ch. NR 661 or exhibits a characteristic identified in subch.
C of ch. NR 661. A healthcare facility may choose to manage its potentially creditable non
-hazardous waste pharmaceuticals as potentially
creditable hazardous waste pharmaceuticals under this subchapter.
NR 666.503(2)
(2)
Accepting potentially creditable hazardous waste pharmaceuticals from an off-site healthcare facility that is a very small quantity generator. A healthcare facility
may accept potentially
creditable hazardous waste pharmaceuticals from an off-site healthcare facility
that is a very
small quanti
ty generator under s.
NR 662.014, without a license or without having interim status, provided the receiving healthcare facilit
y meets all of the following:
NR 666.503(2)(a)
(a) Is under the control of the same person, as defined in s.
NR 660.10 (90), as the very
small quantity generator healthcare facility
that is sending the potential
ly
creditable hazardous waste pharmaceuticals off
-site or has a contractual or other documented business relationship where
by the receiving healthcare facility
supplies pharmaceuticals to the very
small quantity generator healthcare facilit
y. “Control,” for the purposes of this section, means the power to direct the policies of the healthcare facilit
y, whether
by the ownership of stock, voting rights, or otherwise, except that contractors who operate healthcare facilities on behalf of a different person as defined in s.
NR 660.10 may not be deemed to “control” such healthcare facilities.
NR 666.503(2)(b)
(b) Is operating under this subchapter for the management of its potentially
creditable hazardous waste pharmaceuticals.
NR 666.503(2)(c)
(c) Manages the potentially
creditable hazardous waste pharmaceuticals that it receives from off-site in compliance with this subchapter.
NR 666.503(2)(d)
(d) Keeps records of the potentially
creditable hazardous waste pharmaceuticals shipments it receives from off
-site for 3
years from the date that the shipment is received.
NR 666.503(3)
(3)
Prohibition. A healthcare facility is prohibited from sending hazardous wastes other than potentially
creditable hazardous waste pharmaceuticals to a reverse distributor
.
NR 666.503(4)
(4)
Annual reporting by healthcare facilities. A healthcare facility is not subject to annual reporting requirements under s.
NR 662.041 with respect to potential
ly
creditable hazardous waste pharmaceuticals managed under this subchapter.
NR 666.503(5)(a)
(a) A healthcare facility
that initiates a shipment of potentially
creditable hazardous waste pharmaceuticals to a reverse distributor shall keep all of the following records, paper or electronic
, for each shipment of potentially
creditable hazardous waste pharmaceuticals for 3
years from the date of shipment:
NR 666.503(5)(b)
(b) The periods of retention referred to in this section are extended automatically
during the course of a
ny
unresolved enforcement action regarding the regulated activit
y, or as requested by
the department.
NR 666.503(5)(c)
(c) All records shall be readily available upon request by
the department
.
NR 666.503(6)
(6)
Response to spills of potentially creditable hazardous waste pharmaceuticals at healthcare facilities. A healthcare facility
shall immediately contain all spills of potentially creditable hazardous waste pharmaceuticals and manage the spill clean
-up materials as non-creditable hazardous waste pharmaceuticals in accordance with this subchapter.
NR 666.503 History
History: CR 19-082: cr.
Register August 2020 No. 776, eff. 9-1-20; correction in (1) made under s.
35.17, Stats.,
Register August 2020 No. 776.
NR 666.504
NR 666.504 Healthcare facilities that are very small quantity generators for both hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste. NR 666.504(1)(1)
Potentially creditable hazardous waste pharmaceuticals. A healthcare facility
that is a very
small quantity generator for both hazardous waste pharmaceuticals and non
-pharmaceutical hazardous waste may
send its potentially
creditable hazardous waste pharmaceuticals to a reverse distributor
.
NR 666.504(2)
(2)
Off-site collection of hazardous waste pharmaceuticals generated by a healthcare facility that is a very small quantity generator. A healthcare facility
that is a very
small quanti
ty generator for both hazardous waste pharmaceuticals and non
-pharmaceutical hazardous waste may
send its hazardous waste pharmaceuticals off-site to another healthcare facilit
y, provided one of the following is met:
NR 666.504(3)
(3)
Long-term care facilities that are very small quantity generators. A long
-term care facility
that is a very
small quantity
generator for both hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste may
dispose of its hazardous waste pharmaceuticals, excluding contaminated personal protective equipment or clean
-up materials, in an on
-site collection receptacle of an authorized collector, as defined by the drug enforcement administration, that is registered with the drug enforcement administration provided the contents are collected, stored, transported, destr
oyed and disposed of in compliance with all applicable drug enforcement administration regulations for controlled substances.
NR 666.504(4)
(4)
Long-term care facilities with 20 beds or fewer. A long
-term care facility
with 20 beds or fewer is presumed to be a very
small quantity
generator subject to s.
NR 662.014 for both hazardous waste pharmaceuticals and non
-pharmaceutical hazardous waste and not subject to this subchapter, except for ss.
NR 666.505 and
666.507 and the other optional provisions of this section. The department has the responsibility
to demonstrate that a long
-term care facility
with 20 beds or fewer generates quantities of hazardous waste that are in excess of the very
small quantity generator limits as defined in s.
NR 660.10 (139). A long
-term care facili
ty
with more than 20 beds that operates as a very
small quanti
ty generator under s.
NR 662.014 shall demonstrate that it generates quantities of hazardous waste that are within the very
small quantity generator limits as defined in
s. NR 660.10.
NR 666.504 History
History: CR 19-082: cr.
Register August 2020 No. 776, eff. 9-1-20.
NR 666.505
NR 666.505 Prohibition of sewering hazardous waste pharmaceuticals. All healthcare facilities, including very
small quantity generators operating under s.
NR 662.014 in lieu of this subchapter, and reverse distributors are prohibited from discharging hazardous waste pharmaceuticals to a sewer
system that passes through to a publicl
y-owned treatment works. Healthcare facilities and reverse distributors remain subject to the prohibitions in
40 CFR 403.5 (b) (1)
.
NR 666.505 History
History: CR 19-082: cr.
Register August 2020 No. 776, eff. 9-1-20.
NR 666.506
NR 666.506 Conditional exemptions for hazardous waste pharmaceuticals that are also controlled substances and household waste pharmaceuticals collected in a take-back event or program. NR 666.506(1)(1)
Conditional exemptions. Provided the conditions of sub.
(2) are met, all of the following are exempt from the requirements under chs.
NR 662 to
673:
NR 666.506(1)(a)
(a) Hazardous waste pharmaceuticals that are also listed on a schedule of controlled substances
by
the drug enforcement administration in
21 CFR part 1308.
NR 666.506(1)(b)
(b) Household waste pharmaceuticals that are collected in a take-back event or program, including those that are collected
by
an authorized collector, as defined
by
the drug enforcement administration, registered with the drug enforcement administration that commingles the household waste pharmaceuticals with controlled substances from an ultimate user, as defined
by the drug enforcement administration.
NR 666.506(2)
(2)
Conditions for exemption. The hazardous waste pharmaceuticals shall be all of the following:
NR 666.506(2)(b)
(b) Collected, stored, transported, and disposed of in compliance with all applicable drug enforcement administration regulations for controlled substances.
NR 666.506(2)(c)
(c) Destr
oyed
by a method that the drug enforcement administration has publicly
deemed in writing to meet its non-retrievable standard of destruction or combusted at one of the following:
NR 666.506(2)(c)1.
1. A permitted large municipal waste combustor
, subject to
40 CFR part 62 subpart FFF or applicable state plan for existing large municipal waste combustors, or
40 CFR part 60 subpart Eb for new large municipal waste combustors.
NR 666.506(2)(c)2.
2. A permitted small municipal waste combustor
, subject to
40 CFR part 62 subpart JJJ or applicable state plan for existing small municipal waste combustors, or
40 CFR part 60 subpart AAAA for new small municipal waste combustors.
NR 666.506(2)(c)3.
3. A permitted hospital, medical and infectious waste incinerator, subject to
40 CFR part 62 subpart HHH or applicable state plan for existing hospital, medical and infectious waste incinerators, or
40 CFR part 60 subpart Ec for new hospital, medical and infectious waste incinerators.
NR 666.506(2)(c)4.
4. A permitted commercial and industrial solid waste incinerator, subject to
40 CFR part 62 subpart III or applicable state plan for existing commercial and industrial solid waste incinerators, or
40 CFR part 60 subpart CCCC for new commercial and industrial solid waste incinerators.
NR 666.506 History
History: CR 19-082: cr.
Register August 2020 No. 776, eff. 9-1-20.
NR 666.507
NR 666.507 Residues of hazardous waste pharmaceuticals in empty containers. NR 666.507(1)(1)
Stock, dispensing and unit-dose containers. A stock bottle, dispensing bottle, vial, or ampule (not to exceed 1 liter or 10,000 pills); or a unit-dose container (e.g., a unit-dose packet, cup, wrapper, blister pack, or delivery device) is considered empty and the residues are not regulated as hazardous waste provided the pharmaceuticals have been removed from the stock bottle, dispensing bottle, vial, ampule, or the unit-dose container using the practices commonly employed to remove materials from that type of container.
NR 666.507(2)
(2)
Syringes. A
syringe is considered empty and the residues are not regulated as hazardous waste under this subchapter provided the contents have been removed by fully
depressing the plunger of the
syringe
. If a
syringe is not empt
y, the
s
yringe shall be placed with its remaining hazardous waste pharmaceuticals into a container that is managed and disposed of as a non-creditable hazardous waste pharmaceutical under this subchapter and a
ny applicable federal, state, and local requirements for sharps containers and medical waste.
NR 666.507(3)
(3)
Intravenous (IV) bags. An IV bag is considered emp
ty
and the residues are not regulated as hazardous waste provided the pharmaceuticals in the IV bag have been fully administered to a patient. If an IV bag is not empt
y, the IV bag shall be placed with its remaining hazardous waste pharmaceuticals into a container that is managed and disposed of as a non-creditable hazardous waste pharmaceutical under this subchapter, unless the IV bag held non-acute hazardous waste pharmaceuticals and is empty
as defined in s.
NR 661.0007 (2) (a).
NR 666.507(4)
(4)
Other containers, including delivery devices. Hazardous waste pharmaceuticals remaining in all other t
ypes of unused, partially administered, or fully administered containers shall be managed as non
-creditable hazardous waste pharmaceuticals under this subchapter, unless the container held non
-acute hazardous waste pharmaceuticals and is empty as defined in s.
NR 661.0007 (2) (a) or
(b). Examples of containers and delivery devices containing residues may include inhalers, aerosol cans, nebulizers, tubes of ointments, gels, or creams.
NR 666.507 History
History: CR 19-082: cr.
Register August 2020 No. 776, eff. 9-1-20.
NR 666.508
NR 666.508 Shipping non-creditable hazardous waste pharmaceuticals from a healthcare facility or evaluated hazardous waste pharmaceuticals from a reverse distributor. NR 666.508(1)(1)
Shipping non-creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals. A healthcare facility shall ship non-creditable hazardous waste pharmaceuticals and a reverse distributor shall ship evaluated hazardous waste pharmaceuticals off-site to a designated facility, for example a license or interim status treatment, storage, or disposal facilit
y, in compliance with all of the following:
NR 666.508(1)(a)
(a)
Pretransport. Before transporting or offering hazardous waste for transportation off-site, a healthcare facility or reverse distributor shall do all of the following:
NR 666.508(1)(a)2.
2. `Labeling.'
Label each package in accordance with the applicable U.S. department of transportation regulations on hazardous materials under
49 CFR part 172 subpart E.
NR 666.508(1)(a)3.a.a. Mark each package of hazardous waste in accordance with the applicable U.S. department of transportation regulations on hazardous materials under
49 CFR part 172 subpart D.
NR 666.508(1)(a)3.b.
b. Mark each container of 119 gallons or less used in such transportation with the following words and information in accordance with the requirements of
49 CFR 172.304:
“HAZARDOUS WASTE—Federal Law Prohibits Improper Disposal. If found, contact the nearest police or public safety authority or the U.S. Environmental Protection Agency.
Healthcare Facility's or Reverse distributor's Name and Address _____________.
Healthcare Facility's or Reverse distributor's EPA Identification Number_____________.
Manifest Tracking Number_____________.”
NR 666.508(1)(a)3.c.
c. Lab packs that will be incinerated in compliance with s.
NR 668.42 (3) are not required to be marked with EPA hazardous waste numbers, except D004, D005, D
006, D007, D008, D010, and D011, where applicable. A nationally
recognized electronic
system, such as bar coding or radio frequency identification, may
be used to identify
the EPA hazardous waste numbers
.
NR 666.508(1)(a)4.
4. `Placarding.' Placard or offer the initial transporter the appropriate placards according to U.S. department of transportation regulations for hazardous materials under
49 CFR part 172, subpart F
.
NR 666.508(1)(b)1.
1. A healthcare facility
shipping non
-creditable hazardous waste pharmaceuticals is not required to list all applicable EPA hazardous waste numbers, or hazardous waste codes, in Item 13 of EPA form 8700
-22.
NR 666.508(1)(b)2.
2. A healthcare facility shipping non
-creditable hazardous waste pharmaceuticals shall write the word “PHARMS” in Item 13 of EPA form 8700
-22.
NR 666.508(2)
(2)
Exports. A healthcare facility
or reverse distributor that exports non-creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals is subject to subch.
H of ch. NR 662.
NR 666.508(3)
(3)
Imports. Any
person that imports non-creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals is subject to subch.
H of ch. NR 662. A healthcare facility
or reverse distributor may
not accept imported non
-creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals unless they have a license or interim status that allows them to accept hazardous waste from off
-site
.
NR 666.508 History
History: CR 19-082: cr.
Register August 2020 No. 776, eff. 9-1-20.
NR 666.509
NR 666.509 Shipping potentially creditable hazardous waste pharmaceuticals from a healthcare facility or a reverse distributor to a reverse distributor. NR 666.509(1)(1)
Shipping potentially creditable hazardous waste pharmaceuticals. A healthcare facility or a reverse distributor who transports or offers for transport potentially
creditable hazardous waste pharmaceuticals off-site to a reverse distributor shall comply
with all applicable U.S. department of transportation regulations in
49 CFR parts 171 to
180 for a
ny
potentially
creditable hazardous waste pharmaceutical that meets the definition of hazardous material in
49 CFR 171.8.
NR 666.509 Note
Note: For purposes of the department of transportation regulations, a material is considered a hazardous waste if it is subject to the hazardous waste manifest requirements specified in ch.
NR 662. Because a potentially creditable hazardous waste pharmaceutical does not require a manifest, it is not considered hazardous waste under the department of transportation regulations.
